Context Therapeutics® Nominates CTIM-76 Bispecific Antibody Candidate to Develop Treatment for Claudin 6-Positive Solid Tumors
November 29 2022 - 7:30AM
Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq:
CNTX), a women’s oncology company developing novel treatments for
breast and gynecologic cancers, today announced the selection of
CTIM-76, a T cell-engaging bispecific antibody, as its lead
clinical development candidate to target Claudin 6 (CLDN6) positive
cancers, resulting from its research collaboration and licensing
agreement with Integral Molecular.
CLDN6 is differentially expressed on cancer cells with no
or very low expression in normal, healthy tissue. CLDN6-enriched
cancers include ovarian, endometrial, testicular, and gastric,
among others. With the potential to reach a large patient
population and selective expression on cancer cells, CLDN6 has
emerged as an exciting drug target.
Context’s lead candidate, CTIM-76, is a CLDN6 x CD3 bispecific
antibody that incorporates a highly selective CLDN6 binding arm and
a CD3 binding single-chain Fv domain in an IgG format with a
silenced Fc that is designed to be functionally monovalent to avoid
aberrant T-cell activation and to enhance the safety profile.
Research has demonstrated that CTIM-76 is potent with specific
lysis of CLDN6+ cancer cells over normal cells and can activate
cytotoxic T cells without concomitant activation of free cytokines
– critical determinants of immunotherapy safety and activity.
Preclinical studies suggest the potential for convenient dosing
with low immunogenicity risk and manufacturing can be scalable to
address the significant number of patients who are potentially
eligible for CTIM-76 therapy.
“This year has been marked by several exciting and significant
milestones for Context, culminating in naming our lead CLDN6
clinical development candidate, CTIM-76, a bispecific antibody
showing high selectivity for CLDN6,” said Martin Lehr, CEO of
Context Therapeutics. “We selected this bispecific based on the
specificity which suggests its potential to address the need for
potent therapeutic modalities for cancer without compromising
patient safety. With the selection of CTIM-76 as our lead CLDN6
candidate, we are well-positioned to rapidly advance our clinical
development plan in CLDN6-positive tumors including, but not
limited to, ovarian cancer. We have initiated IND-enabling studies
and expect to submit our Investigational New Drug Application (IND)
for CTIM-76 to the U.S. Food and Drug Administration in Q1
2024.”
“Despite being an attractive target, therapeutic monoclonal
antibodies (MAbs) targeting CLDN6 are difficult to discover due to
an abundance of closely related family members and an absolute need
for high specificity. Context and Integral Molecular have been able
to isolate and optimize rare antibodies against CLDN6 that do not
cross-react with other CLDN family members,” said Joseph Rucker,
Ph.D., VP of R&D at Integral Molecular.
R&D WebinarOn Thursday, December 1, 2022,
at 11 a.m. ET, members of the Context team, including management,
and Integral Molecular will host a webinar to discuss the selection
process and nomination of CTIM-76. There will be a
question-and-answer period following the formal presentation. To
register for the webinar, please visit
https://edisongroup.zoom.us/webinar/register/WN_Am1qwkDwRiSYJm51SpP-TQ.
About Context Therapeutics®Context Therapeutics
Inc. (Nasdaq: CNTX) is a clinical-stage biopharmaceutical
company committed to advancing medicines for female cancers. The
Company’s pipeline includes small molecule and bispecific antibody
drug candidates that target cancer signaling pathways. Onapristone
extended release (ONA-XR), a novel, first-in-class potent and
selective progesterone receptor antagonist, is currently in three
Phase 2 clinical trials and one Phase 1b/2 clinical trial in
hormone-driven breast, ovarian, and endometrial cancers. Context is
also developing CTIM-76, a selective Claudin 6 (CLDN6) x CD3
bispecific antibody for CLDN6 positive tumors, currently in
preclinical development. Context is headquartered in
Philadelphia. For more information, please
visit www.contexttherapeutics.com or follow the Company
on Twitter and LinkedIn.
Forward-looking StatementsThis press release
contains “forward-looking statements” that involve substantial
risks and uncertainties for purposes of the safe harbor provided by
the Private Securities Litigation Reform Act of 1995. Any
statements, other than statements of historical fact, included in
this press release regarding strategy, future operations,
prospects, plans and objectives of management, including words such
as "may," "will," "expect," "anticipate," "plan," "intend," and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
forward-looking statements. These include, without limitation,
statements regarding (i) the selectivity, dosing convenience,
potency, binding, scalable manufacturing, and safety profile of
CTIM-76, (ii) the expectation to have an IND submission for CTIM-76
in the first quarter of 2024, (iii) the results of our IND-enabling
studies and clinical trials, (iv) the potential benefits of our
product candidates, (v) the likelihood data will support future
development, and (vi) the likelihood of obtaining regulatory
approval of our product candidates. Forward-looking statements in
this release involve substantial risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by the forward-looking statements, and we, therefore cannot
assure you that our plans, intentions, expectations or strategies
will be attained or achieved. Other factors that may cause actual
results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
our filings with the U.S. Securities and Exchange Commission,
including the section titled “Risk Factors” contained therein.
Except as otherwise required by law, we disclaim any intention or
obligation to update or revise any forward-looking statements,
which speak only as of the date they were made, whether as a result
of new information, future events or circumstances or
otherwise.
Media Contact:Gina Cestari6
Degrees917-797-7904gcestari@6degreespr.com
Investor Relations Contact:Laine YonkerEdison
Grouplyonker@edisongroup.com
Context Therapeutics (NASDAQ:CNTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Context Therapeutics (NASDAQ:CNTX)
Historical Stock Chart
From Apr 2023 to Apr 2024